Levels of Visfatin/NAMPT in Human Milk (VISFAMILK)

Levels of Visfatin/NAMPT in Human Milk.VISFAMILK

Visfatin, released in maternal milk at different concentrations related to the maternal conditions, could act as a biomarker with a prognostic/predictive value to determine different newborn clinical conditions, particularly the weight loss of the neonate.

Study Overview

• Status: Recruiting
• Conditions: Birth Weight; Visfatin Levels in Maternal Milk Samples
• Intervention / Treatment: Other: observational study

Detailed Description

The aim of the study is to analyse a retrospective cohort of well characterized mothers in their post-partum period, and to measure Visfatin levels through collection of maternal milk samples. They will be collected in three different moments after the birth (48 hours, 7 days and 30 days) and Visfatin levels will be analysed through an ELISA kit Adipogen. In parallel, the levels of Visfatin will be evaluated in the maternal plasma/serum collected after 1-2 days postpartum.

Lastly, correlations between Visfatin levels and biological/clinical features of mothers and newborns will be explored.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Paolo Manzoni, Professor; Phone Number: +39 01515156906; Email: paolo.manzoni@aslbi.piemonte.it

Study Locations

• Italy
  • BI
    • Ponderano, BI, Italy, 13875
      • Recruiting
      • Ospedale degli Infermi - ASL BI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

30 women, hospitalized after childbirth, with respective healthy, breastfed infants

Description

Inclusion Criteria:

• Healthy male and female infants born after 37 weeks' gestation who do not have conditions related to congenital abnormalities
• Maternal hospitalization
• Acquisition of the informed consent form signed by the patient

Exclusion Criteria:

• Refusal of the patient to participate in the study
• Presence of hypogalactia or agalactia in the patient

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visfatin levels	Visfatin levels in maternal milk samples	48 hours, 7 days and 30 days
Visfatin levels	Visfatin levels in maternal plasma/serum	1-2 days post-partum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
values of Visfatin	correlate the values of Visfatin to different demographic and clinical characteristics of the lactating mothers	6 months
values of Visfatin	correlate the values of Visfatin to different biological/clinical features of the newborns; in particular, we will focus attention on the weight loss of the neonate	6 months

Collaborators and Investigators

• Sponsor: Paolo Manzoni Study Group
• Collaborators: Università degli Studi del Piemonte Orientale Amedeo Avogadro

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Estimated): April 23, 2025
• Study Completion (Estimated): April 23, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Newborns; Breastfeeding; Visfatin
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No